Balloon catheter pressure relief valve

ABSTRACT

A pressure relief apparatus for a balloon dilation catheter having a shaft with a dilation balloon attached to the distal end of the shaft and an inflation/deflation lumen for inflating and deflating the balloon includes a pressure relief port formed through the wall of the inflation/deflation lumen with a pressure relief member secured across the pressure relief port to form a fluid tight seal such that the fluid tight seal formed by the pressure relief member fails at a predetermined pressure to release pressure from the inflation/deflation lumen through the pressure relief port.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/390,573, filed Feb. 23, 2009, entitled BALLOON CATHETER PRESSURERELIEF VALVE (Atty. Dkt. No. FMED-28934), now U.S. Pat. No. 8,814,899,issued Aug. 26, 2014, the specifications of which are incorporated byreference herein in their entirety.

TECHNICAL FIELD

The disclosure relates to dilation balloon catheters and, in particular,dilation balloon catheters having a pressure relief valve for limitingthe amount of pressure that may be applied to the balloon.

BACKGROUND

Angioplasty is the technique of mechanical widening a narrowed ortotally obstructed blood vessel; typically as a result ofatherosclerosis. A catheter is used to maneuver a tightly folded balloonattached to the distal end of the catheter into the narrowed location(stenosis). An incompressible fluid is then pumped through the catheterto inflate the balloon and enlarge the narrowed portion of the bloodvessel. Relatively high pressures, in some instances up to 30atmospheres, may be used to inflate the balloon. After the procedure iscomplete, a negative pressure may be applied through the catheter toremove the incompressible fluid, deflating the balloon for removal fromthe blood vessel.

Catheter dilation balloons are typically provided with a rated operatingpressure and a rated burst pressure. The rated operating pressure is thepressure at which the balloon reaches its nominal diameter. The ratedburst pressure is a statistical measure, e.g., typically a maximumpressure at which there is a 95% confidence level that 99.99% ofballoons will not fail. Non-compliant catheter balloons are typicallyused at pressures between the rated operating pressure and the ratedburst pressure.

However, due to the high pressures used in many cases to inflate adilation catheter balloon during angioplasty and the relatively smallvolume of the balloons used, there is a potential to pressurize adilation balloon beyond its rated burst pressure. Further, in someinstances a dilation catheter balloon may be inflated and deflatedmultiple times during angioplasty, weakening the balloon. If a balloonbursts during angioplasty, there is a possibility that portions of theballoon may separate from the catheter, possibly necessitating surgeryto remove the separated portions of the balloon from the patient'sartery. Thus, there exists a need for a means of preventingover-inflation of dilation balloons during procedures such asangioplasty.

SUMMARY

In one aspect thereof, a pressure relief apparatus for a balloondilation catheter is provided. The balloon dilation catheter includes ashaft having a dilation balloon attached to the distal end of the shaft,an inflation/deflation lumen for inflating and deflating the balloon anda pressure relief port formed through the wall of theinflation/deflation lumen. A pressure relief member is secured acrossthe pressure relief port to form a fluid tight seal. The fluid tightseal is configured to fail (e.g. burst, rupture, tear or leak) at apredetermined pressure to release pressure from the inflation/deflationlumen through the pressure relief port. The predetermined pressure maybe greater than or equal to the rated burst pressure of the dilationballoon.

In one variation, the pressure relief port comprises a first outwardlyopening passage and a second passage in fluid communication with thefirst passage. The second passage extends inwardly from the firstpassage and opens into the inflation/deflation lumen. In this variation,the cross-sectional area of the first passage may be larger than thecross-sectional area of the second passage.

In one embodiment, a wall extends radially between an inside end of thefirst passage of the pressure relief port and an outside end of thesecond passage of the pressure relief port. The pressure relief membermaybe disposed adjacent the wall and across the outside end of thesecond passage of the pressure relief port to block the pressure reliefport and form a fluid tight seal. The pressure relief member may be aplastic film, a thin metallic film or a similar material. A retainer forretaining the pressure relief member in the pressure relief port may beutilized such that the pressure relief member and retainer form a fluidtight seal across the pressure relief port.

In another aspect, a pressure relief apparatus for a dilation catheterhaving a balloon with a rated burst pressure includes a hub adapted forconnection to a proximal end portion of a balloon dilation cathetershaft wherein a pressure relief port is formed in the hub. In oneembodiment, the hub may comprise a plastic a body that defines aninflation/deflation lumen and a guidewire lumen.

The hub may be formed from a substantially rigid material and includes awall defining the inflation/deflation lumen for directing asubstantially incompressible inflation medium into and from aninflation/deflation lumen of the catheter shaft. The hub includes apressure relief port formed through the wall of the hub and a pressurerelief member disposed across the pressure relief port to form a fluidtight seal across the pressure relief port. The pressure relief memberis configured to fail, (e.g. rupture, tear, burst or leak), at apredetermined pressure to release pressure from the inflation/deflationport through the pressure relief port.

In one configuration the relief port includes a first outwardly openingpassage and a second passage in fluid communication with the firstpassage. The second passage extends inwardly from the first passage andopens into the inflation lumen of the hub. A wall extends radiallybetween an inside end of the first passage of the pressure relief portand an outside end of the second passage of the pressure relief port. Inthis variation, the pressure relief member may be disposed adjacent thewall and across the outermost end of the second passage of the pressurerelief port. The pressure relief member may be secured against the walland across the outside end of the second passage with a retainerpositioned in the first passage whereby the pressure relief member andretainer form a fluid tight seal across the pressure relief port.

In another aspect, a dilation catheter having a pressure reliefapparatus includes a catheter shaft having a proximal end portion and adistal end portion with a dilation balloon having a rated burst pressureattached to the distal end portion of the catheter shaft. The cathetershaft includes an outer tubular member that forms an inflation/deflationlumen extending through the catheter shaft from adjacent the proximalend portion of the catheter shaft to the balloon such that theinflation/deflation lumen is in fluid communication with the balloon. Ahub is connected to the proximal end portion of the catheter shaft. Thehub may be formed from a substantially rigid material and has a walldefining an inflation/deflation lumen for directing a substantiallyincompressible inflation medium into and from the inflation/deflationlumen of the catheter shaft.

In one variation, the pressure relief apparatus includes a pressurerelief port is formed through the wall of the hub. The pressure reliefport may include a first outwardly opening passage and a second passagein fluid communication with the first passage and extending inwardlyfrom the first passage and opening into the inflation/deflation lumen.In one embodiment, the diameter and cross-sectional area of the firstpassage is larger than the diameter and cross-sectional area of thesecond passage. A pressure relief member may be disposed adjacent anannular wall that extends between an inside end of the first passage ofthe pressure relief port and an outside end of the second passage of thepressure relief port. The pressure relief member blocks the pressurerelief port, forming a fluid tight seal at pressures less than the ratedburst pressure of the balloon. A retainer positioned in the firstpassage may be utilized to retain the pressure relief member against theannular wall. In one variation, the pressure relief member is one ormore layers of a plastic film, in other variations the pressure reliefmember may be a thin layer of metallic material.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding, reference is now made to thefollowing description taken in conjunction with the accompanyingDrawings in which:

FIG. 1 illustrates a balloon dilation catheter according to thedisclosure;

FIG. 2 is cross-sectional of the shaft of the catheter of FIG. 1, takenalong line 2-2 of FIG. 1;

FIG. 3 is a length-wise section view of the hub of the balloon dilationcatheter of FIG. 1,

FIG. 4 is an enlarged view of a portion of the sectional view of FIG. 3further illustrating the pressure relief port;

FIG. 5 is an end view of the pressure relief port of FIG. 4; and

FIG. 6 is a length-wise section view of an alternate hub for use with aballoon dilation catheter.

DETAILED DESCRIPTION

Referring now to the drawings, wherein like reference numbers are usedherein to designate like elements throughout, the various views andembodiments of a balloon catheter pressure relief valve are illustratedand described, and other possible embodiments are described. The figuresare not necessarily drawn to scale, and in some instances the drawingshave been exaggerated and/or simplified in places for illustrativepurposes only. One of ordinary skill in the art will appreciate the manypossible applications and variations based on the following examples ofpossible embodiments.

Turning now to FIG. 1 a balloon dilation catheter 100 includes a shaft102 having a proximate end 104 and a distal end 106. In one variation, aplurality of tubular members disposed in catheter 100 define internal,longitudinally extending passages known as lumens. An access fitting orhub 110 is affixed to the proximal end of catheter shaft 102 to provideaccess to the lumens. One tubular member, the guidewire tubular member120, extends longitudinally through the catheter from hub 110 to thedistal end 124 of dilation balloon 108. The guidewire tubular member 120has a bore defining a guidewire lumen through which a conventionalguidewire 116 may be directed through the interior of catheter 100.

As illustrated, hub 110 includes a first port 112 for receivingguidewire 116 therethrough and directing the guidewire into theguidewire lumen in shaft 102. Hub 110 further includes a secondinflation/deflation port 114 adapted to receive an incompressibleinflation medium and direct the medium into an inflation/deflation lumenthat extends through the hub and shaft 102. As illustrated, hub 110includes a pressure relief port 134 that extends through the wall of thehub and into the inflation/deflation lumen of the hub. A manipulator 118may be provided for rotating and positioning guidewire 116 from theproximal end of catheter 100.

Referring still to FIG. 1, the proximal end 122 of dilation balloon 108is affixed to the distal end 106 of shaft 102. In the case ofnon-compliant balloons typically used in angioplasty, balloon 108 may beof conventional construction and is typically formed of relativelynon-distensible plastic or polymer material such as nylon. Non-compliantballoons will typically expand less than about 10%, and more typicallyless than about 5%, when pressurized from the rated operating pressureto the balloon's rated burst pressure.

The envelope of balloon 108 may be plain or reinforced with filaments orfibers. For the purpose of illustration, balloon 108 is shown in aninflated configuration in FIG. 1 with portions of the balloon cut awayto better to illustrate the interior structure of catheter 100. Althoughballoon 108 is illustrated in an inflated configuration, it will beappreciated that when deflated the balloon can typically be folded insuch a manner as to have an outside diameter or cross sectionapproximately equal to that of catheter shaft 102.

The proximate end 122 of balloon 108 may be attached to the distal end106 of shaft 102 of shaft 102 using various techniques known in the art,for example with an appropriate adhesive such as medical grade epoxyadhesive. The distal end 124 of balloon 108 is connected with afluid-tight seal to the outside (i.e. radial) surface of guidewiretubular member 120, which, as illustrated, extends beyond the distal end106 of the catheter shaft 102, passing through the interior of balloon108. The distal end 124 of balloon 108 may be welded to guidewiretubular member 120 or adhered to the guidewire tubular member with anappropriate adhesive to form a fluid-tight seal.

FIG. 2 is a cross-sectional view of catheter shaft 102 taken along line2-2 of FIG. 1. In one embodiment, catheter shaft 102 may have a coaxialconfiguration wherein guidewire tubular member 120 defines a guidewirelumen 126. An outer tubular member 132 extends coaxially with guidewirelumen 126 and defines an annular inflation/deflation lumen 128 betweenthe inside surface of the outer tubular member and the outside surfaceof guidewire tubular member 120. Inflation/deflation lumen 128 extendsfrom inflation/deflation port 114 of hub 110 to balloon 108, providing afluid passageway for the incompressible fluid used to inflate theballoon. Catheter shaft 102 may include a coating 130 to increase thelubricity of the catheter shaft.

Outer tubular member 132 and guidewire tubular member 120 may be formedfrom a variety of suitable plastic materials such as nylon-11, nylon-12and/or a polyether block amide (PEBA). In one embodiment, guidewiretubular member 120 and/or outer tubular member 132 may be formed fromPEBA elastomers sold under the trademark Pebax®. PEBA elastomers areavailable in plasticizer and additive-free medical grades having anominal hardness (Shore D) from about Shore D 30 to about Shore D 72.The thermoplastic materials used to make guidewire tubular member 120and outer tubular member 132 may be loaded with materials such as carbonnanotubes or similar materials in order to enhance the strength of thetubular members. In other variations, guidewire tubular member 120and/or outer tubular member 132 may be loaded with up to approximatelytwenty percent by weight of a radiopaque material such as bismuth.

FIG. 3 is a length wise sectional view of a hub 200 according to thedisclosure. Hub 200 may be molded from an appropriate plastic such asnylon and includes a substantially rigid cylindrical wall 202 having aproximate end 204 and a distal end 206. In one embodiment hub 200 mayinclude a separately molded end cap 211 that is glued into the distalend of the hub with an appropriate adhesive to facilitate assembly ofthe hub.

Cylindrical wall 202 defines a central passage 205 extendinglongitudinally through hub 200. An outer tubular member 208 of acatheter shaft may be inserted into the distal end passage 205 andsecured to an inside surface of cylindrical wall 202 with an adhesivesuch as a medical grade epoxy to provide a fluid tight seal. A guidewiretubular member 210 is positioned inside outer tubular member 208.Guidewire tubular member 210 extends past the proximate end of the outertubular member 208 and may be secured to the inside surface ofcylindrical wall 202 with an appropriate adhesive to form a fluid tightseal. Guidewire tubular member 208 and the inside surface of cylindricalwall 202 proximate to the end of guidewire tubular member define aguidewire lumen 212 extending through hub 200. In one variation, anenlarged portion 216 of the proximate end of passage 205 serves as aguide for inserting or threading guidewire 232 into hub 200.

The inside surface of wall 202 and the outside surface of guidewiretubular member 210 define an annular inflation/deflation lumen 214within hub 200 that extends distally from the location where guidewiretubular member 210 is sealed against the inside surface of wall 202.Inflation/deflation lumen 214 extends from hub 200 between the insidesurface of the outer tubular member 208 and the outside surface ofguidewire tubular member 210 to a dilation balloon such as balloon 108of FIG. 1. Hub 200 includes an inflation/deflation port 218 throughwhich an incompressible fluid (e.g. inflation medium) may be directedinto and out of the hub. In one variation, inflation/deflation port 218comprises a cylindrical wall 207 that may be integrally molded with wall202. As illustrated, wall 207 defines a passageway 211 that opens intoinflation/deflation lumen 214 at a location distal to the fluid tightseal between guidewire tubular member 210 and the inside surface ofcylindrical wall 202. In the illustrated embodiment, cylindrical wall207 includes an enlarged end 209 to facilitate connection of a source ofpressurized fluid to hub 200.

Referring still to FIG. 3, a pressure relief port 220 is formed throughcylindrical wall 202. Pressure relief port 220 opens intoinflation/deflation lumen 214 and a pressure relief member 222 issecured across the pressure relief port to form a fluid tight seal. Inone embodiment, pressure relief member 222 may be one or more layers ofa suitable plastic film having a tensile strength such that filmruptures or tears when the pressure in inflation/deflation lumen 214exceeds a predetermined value, for example a selected pressure between 6and 30 atmospheres. The predetermined pressure value may beapproximately equal to the rated burst pressure of a dilation balloonused with a catheter incorporating hub 200. In other variations, thepredetermined value may be greater than or less than the rated burstpressure of the balloon.

FIG. 4 is an enlarged view of the encircled portion of FIG. 3 furtherillustrating relief port 220. As illustrated, relief port 220 includesan enlarged outwardly opening passage 226 and a smaller diameter innerpassage 228 that opens into inflation/deflation lumen 214. An annularwall 230 extends radially between outwardly opening passage 226 andinner passage 228. As illustrated, pressure relief member 222 extendsacross inner passage 228 and annular wall 230. Pressure relief member222 may be glued to annular wall 230 with an appropriate adhesive, suchas a medical grade epoxy, to form a fluid-tight seal across relief port220. In other embodiments, pressure relief member 222 may be solventwelded or thermally or ultrasonically welded in place. In oneembodiment, a cylindrical retainer 224 is positioned in outwardlyopening passage 226 over pressure relief member 222. In the embodimentshown in FIG. 4, pressure relief member 222 is positioned betweenretainer 224 and annular wall 228.

FIG. 5 is an enlarged end view of relief port 220. As illustrated,retainer 224 has an outside diameter approximately equal to the insidediameter of outwardly opening passage 226 and a centrally locatedcylindrical opening 234 having a diameter approximately equal to thediameter of inner passage 228 through which pressure relief member 222is exposed. Retainer 224 may be secured in outwardly opening passage 226and/or to pressure relief member 222 with an appropriate adhesive or bymeans of solvent, thermal or ultrasonic welding.

In the illustrated embodiments, relief port 220 has a generally circularconfiguration. However, in other embodiments relief port 220 may berectangular, oval or polygonal. In other variations relief member 222and retainer 224 may be formed as a single integral component by meansof, for example, molding. In yet other embodiments, pressure reliefmember 222 may be scored or otherwise weakened in order to burst at aselected predetermined pressure. Although as illustrated, pressurerelief member 222 is formed from one or more layers of a plastic film,it is contemplated that the relief member may be formed form othermaterials having the same or different geometries. For example, pressurerelief member may be formed as a thin metal disk having a flat or curvedcross-section.

Turning to FIG. 6, in an alternate embodiment, a catheter hub 300comprises a substantially rigid, integrally formed body 302 having aproximate end 304 and a distal end 306. Body 302 may be molded from asuitable plastic such as nylon. A guidewire tubular member 310 passesthrough a longitudinally extending central passage 312 formed in body302. A proximate portion of guidewire tubular member 310 is encased in afirst outer tubular member 308 that extends into the proximate end ofcentral passage 312. First outer tubular member 308 and guidewiretubular member 310 are secured in position in hub 300 with an adhesive326 that forms a fluid tight seal between the guidewire tubular memberand the inside surface of central passage 312. A second outer tubularmember 314 is positioned over guidewire tubular member 310 and securedin central passage 312 at the distal end 306 of hub 300 with anappropriate adhesive or by means of thermal, solvent or ultrasonicwelding. The inner surface of central passage 312 and the outer surfaceof guidewire tubular member 310 define an annular inflation/deflationlumen 328 that extends from hub 300 between the outer surface ofguidewire tubular member 310 and the inner surface of second outertubular member 314.

Referring still to FIG. 6, an inflation/deflation tube 316 is secured inan inflation/deflation port 318 is formed in body 302 for providingpressured fluid through hub 300 to a dilation balloon.Inflation/deflation tube 316 may be secured in inflation/deflation port318 by means of an adhesive or by thermal, ultrasonic or solventwelding. As illustrated, inflation/deflation port 318 is formed at anacute angle to central passage 312 and opens into inflation deflationlumen 328 distal to the fluid tight seal formed by adhesive 326 betweenthe inside surface of the central passage and guidewire tubular member310.

A pressure relief port 320 formed in body 302 extends outwardly frominflation/deflation lumen 328 at a location distal to the fluid tightseal formed by adhesive 326 between the inside surface of the centralpassage and guidewire tubular member 310. In one variation, pressurerelief port 320 is essentially identical to pressure relief port 220 ofFIGS. 4 and 5. A pressure relief member 322 is secured across pressurerelief port 320 to form a fluid tight seal. In one embodiment, acylindrical retainer 324 is used to secure pressure relief member 322across pressure relief port 320. Pressure relief member 322 is formedfrom a material, such as a plastic film, such that the member willrupture or tear when the pressure in inflation/deflation lumen 328reaches or exceeds a predetermined level. In one variation, thepredetermined pressure is equal to or greater than the rated burstpressure of the dilation balloon connected to hub 300.

Referring to FIGS. 3 and 6 it will be appreciated that in the event thata pressure relief member 222 or 322 is ruptured or fails duringangioplasty or during stent placement, balloon 108 (FIG. 1) may remainin an inflated or partially inflated condition in a patient's bloodvessel. Depending upon the particular situation, it may be difficult orimpossible to remove the balloon from the blood vessel withoutcompletely deflating the balloon. Further, the blood vessel may remainoccluded for longer than desired if the balloon cannot be deflated withthe use of negative pressure. This may be particularly problematic inthe case of a substantially inelastic non-compliant or semi-compliantballoon since the balloon may not collapse or only partially collapsewithout the use of negative pressure to aspirate the incompressiblefluid from the balloon.

Referring still to FIGS. 3 and 6, pressure relief ports 220 and 320 arelocated in hubs 200 and 300 at locations where the ports may be rapidlysealed in the event of a rupture of pressure relief members 222 or 322.For example, in the case of a rupture of pressure relief member 222 or322, a practitioner may place a finger or thumb over the pressure reliefport to seal the port and then apply a negative pressure to balloonthrough the catheter to aspirate the fluid from the balloon.Alternatively, a piece of tape or similar material may be placed overpressure relief ports 220 or 320 to seal the port while the balloon isdeflated. Thus, while pressure relief ports 220 and 320, along withrelief members 222 and 322 provide a means of preventing over-inflationof dilation balloons during procedures such as angioplasty, the portsmay also be rapidly re-sealed to allow for rapid controlled deflation ofa dilation balloon in the case of a rupture of the relief member.

While the pressure relief ports and apparatus described above are formedin a wall of a catheter hub, it is contemplated that the ports could bepositioned in a wall of the catheter shaft or in an inflation/deflationport connected to the hub. Further, while the pressure relief ports aredescribed in connection with catheters having coaxially configuredcatheter shafts, the ports may be adapted for use with other types ofcatheters. Such catheters may have non-coaxial multi-lumen shafts suchas extruded dual lumen shafts. Additionally, while the pressure reliefapparatus had been described in connection with non-compliant dilationballoons, the apparatus may be used with semi-compliant and complaintballoons.

It will be appreciated by those skilled in the art having the benefit ofthis disclosure that this balloon catheter pressure relief valveprovides a means of preventing over-pressurization of a dilationcatheter balloon. It should be understood that the drawings and detaileddescription herein are to be regarded in an illustrative rather than arestrictive manner, and are not intended to be limiting to theparticular forms and examples disclosed. On the contrary, included areany further modifications, changes, rearrangements, substitutions,alternatives, design choices, and embodiments apparent to those ofordinary skill in the art, without departing from the spirit and scopehereof, as defined by the following claims. Thus, it is intended thatthe following claims be interpreted to embrace all such furthermodifications, changes, rearrangements, substitutions, alternatives,design choices, and embodiments.

What is claimed is:
 1. A pressure relief apparatus for a balloondilation catheter including a shaft having a dilation balloon attachedto the distal end of the shaft and an inflation/deflation lumen forinflating and deflating the balloon comprising: a pressure relief portformed through the wall of the inflation/deflation lumen; a pressurerelief member secured across the pressure relief port to form a fluidtight seal; and wherein the fluid tight seal formed by the pressurerelief member fails at a predetermined pressure to release pressure fromthe inflation/deflation lumen through the pressure relief port.